Musculoskeletal News Roundup 13-Nov-08
BY LAUREN UZDIENSKI, NOVEMBER 13, 2008
Earnings
aap Implantate AG reported sales for the first nine months of 2008 of EUR 24.2 million ($35.0 million), up 30% from the same period last year. The company attributed the sales growth to the Traumatology & Orthopaedics division, where sales have increased by approximately 57% over last year.
Artimplant reported 3Q:08 net revenue of SEK 2.3 million ($0.34 million), down 12% over the year-ago period. The net loss for the period was SEK 4.3 million ($0.64 million), or SEK (0.07) ($0.01) per share. During the quarter, there were 1,000 Artelon Spacers sold, up from 700 in the same period last year, and 300 Artelon Tissue Reinforcement devices sold, up from 150 in 3Q:07.
BioMimetic Therapeutics reported 3Q:08 revenues of $0.4 million, comprised of royalty and sublicense fee income, down from $1.67 million in 3Q:07. Revenues missed estimates by $0.1 million. The company reported a net loss of a net loss of $18.0 million, or $(0.97) per diluted share. Analysts had forecast a net loss of ($0.46) per share. Among clinical updates: 330 patients have been enrolled in the Augment Bone Graft North American pivotal trial, which will ultimately enroll 396 patients at 34 sites; and the EU Augment clinical study with Augment Bone Graft for the treatment of foot and ankle fusions has been completely enrolled at 108 patients.
Corin shares fell on the company's announcement that 2008 pretax profit will be below market estimates on account of Stryker purchasing fewer Cormet systems than anticipated. Analysts had expected profit of 4.24 million pounds ($6.56 million). Chief Executive Peter Huntley said, "[Cormet] has become a longer-term growth programme, more of a normal growth profile for an orthopedic [product] than was originally anticipated."
Integra LifeSciences reported 3Q:08 revenue of $167.0 million, representing a 24% increase over 3Q:07 and beating estimates by $5.5 million. Organic growth was 11%. Integra Orthopedic sales, which included the Extremity Reconstruction, Integra OrthoBiologics, Integra Spine and private label product lines, increased by 63% to $53.8 million. IsoTis and Theken Spine revenues contributed $16.2 million. Extremity reconstruction was up "more than 20%," while private label revenues were flat. Adjusted net income was $13.3 million, or $0.46 per diluted share, missing estimates by a penny.
Osteotech reported 3Q:08 revenue of $24.1 million, down 6% from the year-ago period and missing estimates by $2.8 million. The company said the decline in revenue was driven by a reduction in private label DBM revenue, which was partially offset by a 6% increase in baseline revenue, which includes the company's Grafton, Xpanse, Plexur and traditional tissue franchises. Net income was $58 thousand ($0.00/share), down from $1.6 million ($0.09/share) in 3Q:07. Analysts had forecast EPS of $0.02.
Symmetry Medical reported 3Q:08 of $112.1 million, representing a 48% increase over the year-ago period and beating estimates by $6.0 million. 3Q:08 net income was $2.5 million. Adjusted earnings per share was $0.19, missing estimates by a penny. President and CEO Brian Moore said, "We have continued to operate at a high level of capacity . . . While demand from major orthopaedic customers remained strong through the quarter, which we believe will be sustained through year-end and into 2009, we remain cautious in view of the economic environment."
M&A
Nobel Biocare signed an agreement to acquire BioCad Medical Inc., a developer of computer-aided software for prosthetics. The transaction is valued at EUR 26 million ($33.4 million). Nobel also signed an exclusive partnership with Optimet, Optical Metrology Ltd, to offer optical scanners with impression scanning capabilities. In addition to the acquisition and Optimet deal, Nobel Biocare plans to introduce new prosthetic materials and products at industry conferences in early 2009.
Regulatory
Amedica received CE Mark approval for its Valeo line of ceramic spinal intervertebral spacers. The spacers are composed of a silicon nitride ceramic and were cleared in the U.S. in January of 2008 as vertebral body replacements.
Product Introduction & Update
Osteotech will market its next-generation grafting material under the brand name MagniFuse Bone Graft. The product will consist of allograft bone within a polymer mesh and is expected to be available in mid-2009.
License Agreements
K2M entered into an agreement with Promethean Surgical Devices for worldwide exclusive rights for all spinal applications of an injectable polymer technology. The company says the technology could have applications for nucleus degeneration or less invasive surgical approaches for annular repair.
Partnerships
Zimmer announced plans to collaborate with the American Orthopaedic Association to fund post-graduate orthopedic fellowships and residencies through the OMeGA Medical Grants Association. The company will not be part of the selection process, but they will be able to select which specialties they'd like to support (e.g., recon, shoulder and elbow, spine, etc.)
Appointments
Baxano appointed Tony Recupero Executive Vice President of Sales and Marketing. Mr. Recupero was previously Vice President of Sales at Kyphon.
Stryker announced several organizational changes this week. Si Johnson, Group President, MedSurg, announced plans to retire; he will remain as an advisor to the company through 2009. Dean Bergy, Vice President, Chief Financial Officer will leave the company after 1Q:09, when Curt Hartman, currently Global President of the Instruments division will assume the full role of Chief Financial Officer. Additionally, Tim Scannell is promoted to the role of Group President, Stryker Spine and Endoscopy.
